Tampon trial to help improve early diagnosis of ovarian cancer

A new trial is testing whether a specialist medical tampon could help improve early diagnosis of ovarian cancer.

A team of researchers in Southampton has launched a study which will use the tampon, plus other methods of sample collection. They will look for the earliest clues that cancer may be present, particularly in women at a higher risk of developing the disease.

The trial is being led by Dr Jemma Longley, Consultant Medical Oncologist at University Hospital Southampton (UHS).

She is working with colleagues from the Southampton Clinical Trials Unit (SCTU) and the Centre for Cancer Immunology at the University of Southampton. UHS is the trial sponsor.

The need for better diagnosis

Ovarian cancer is the 6th most common cancer in women in the UK. On average, 21 people a day are diagnosed with the disease.

Yet only around 27% of cases are diagnosed in the early stages. This means many cases are only picked up when the cancer is more advanced and there are fewer treatment options available.

Women with a mutation in specific genes, including the BRCA gene, are at a much higher risk of developing ovarian cancer.

“There is currently no screening programme available for ovarian cancer, and women with recognised genetic mutations, such as BRCA, may opt to have surgery to remove their ovaries and fallopian tubes to reduce their risk of developing the disease,” says Dr Longley.

“However, this can have significant long-term health effects, by putting younger women into a surgical menopause.

“In the VIOLET study, we will take samples of vaginal fluid from women who are undergoing surgery to reduce their ovarian cancer risk using the diagnostic tampon and vaginal swabs.

"We will also take tissue samples from the removed ovaries and fallopian tubes, and compare the samples from women with the earliest signs of ovarian cancer to those without cancer.

“If we find changes to biomarkers called microRNAs – tiny biological signals that are present in both the ovarian cancer cells and the vaginal fluid – this could indicate a way to predict ovarian cancer in the future.”

Charlotte's experience

Mum-of-two Charlotte Stehr, 35, was diagnosed with a BRCA gene mutation in early 2020.

She had a double mastectomy later that year, as BRCA is also associated with an increased risk of breast cancer. She also had gene testing, to ensure she didn’t pass the mutation on to her children. However, she knows she is still at risk from ovarian cancer.

“I had some complications after my C-section for my son’s birth, and they found that I have cysts on my ovaries. And I was just terrified because, with ovarian cancer, there's a lower survival rate and the symptoms can be misdiagnosed.

“I am under the care of the oncology team since my mastectomy, but I’m just so scared that I will just slip through the cracks. And at the moment I am not recommended for preventative surgery to remove my ovaries because I'm under 40.”

Charlotte is a project manager from Romsey in Hampshire. She believes a screening programme that could pick up the early signs of ovarian cancer could be a lifeline for people like her, and other women whose symptoms may not be obvious.

“I don't want future generations, or other women like me with a known risk factor, being in this same position. Or someone losing their mum at 40 because cancer wasn’t picked up in time.

“I think this sort of research is amazing. Women have been using tampons for years, so why would you not want to use one that could actually help you? And for people who are working, or have busy family lives, or are scared of going to the doctors, then you could do it without really impacting your day-to-day life.”

Alison's experience

65-year-old Alison Farmer knows only too well the importance of early diagnosis.

Alison is a retired psycho-oncology nurse from Southampton. She was diagnosed with ovarian cancer at age 40, after experiencing unusual bleeding.

“I immediately went to see the GP, but was told that many women get unexpected bleeding. Perhaps due to my background and my job, I asked to see a gynaecologist, and a cyst was found which turned out to be a cancer.

“It was a surprise to pretty much everybody, partly because of my age. I think if I hadn't been a nurse and pushed for further tests, I probably wouldn't be here today.”

Thankfully, Alison’s cancer was caught at an early stage. She underwent surgery to remove her ovaries and had chemotherapy to treat the cancer. But she is very aware that too many cases of ovarian cancer are diagnosed late.

“I think a lot of women have mild, subtle symptoms and think ‘it's nothing’, or ‘I haven't got time to go to the doctors’. I also think there's a lack of awareness about the typical symptoms of gynaecological cancers, such as bloating, feeling full, frequency of urination and discomfort.

“Research into screening and earlier diagnosis is absolutely vital. Far too many women are still diagnosed too late. I've lost friends, sadly, who were diagnosed at stage 3 and 4. So, something like this new study with the tampon is very exciting.”

Finding the evidence

The VIOLET study recently started recruiting participants who are undergoing risk-reducing surgery at UHS.

Dr Victoria Goss is Head of Early Diagnosis and Translational Research at the SCTU. She is a co-investigator on the study.

“This is an exciting trial in an area where better diagnosis is desperately needed,” she said.

“It aligns with the Government’s recent announcement on the Women’s Health Strategy to help overcome gender inequalities in healthcare, and we see our research as a vital part of efforts to improve outcomes for women with ovarian cancer.”

The study is funded by a grant from The Eve Appeal, with support from the Southampton Experimental Cancer Medicine Centre. The diagnostic tampons used in the study are supplied by biotechnology company Daye.

Mr David Constable-Phelps, consultant gynaecological oncology surgeon at UHS, is a co-investigator on the study.

“The ability to detect the earliest signs of ovarian cancer, with a relatively non-invasive test such as the Daye tampon, would be a complete game-changer for women with ovarian cancer,” he says.

“Ovarian cancer commonly has non-specific symptoms in its early and late stages, so the tumour can spread to other organs silently.

“We are really optimistic that we will find interesting biological signals in the vaginal fluid of women with early-stage tumours, meaning more women can expect to be cured. This study will pave the way towards further translational work to allow us to understand more about the biology of these cancers.”

Dr Longley is the study’s chief investigator. She says they hope this study will identify potential biomarkers that pick up early signs of ovarian cancer in vaginal fluid.

“If successful,” she says, “it would lead to a much larger trial to develop a community-based screening test in women at high risk of ovarian cancer to catch more cancers in their earliest stages.”